Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-22 @ 1:10 PM
Study NCT ID:
NCT05520658
Status:
UNKNOWN
Last Update Posted:
2022-08-30
First Post:
2022-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5 - Fluorouracil in Treatment of Plantar Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-12', 'releaseDate': '2024-08-29'}], 'estimatedResultsFirstSubmitDate': '2024-08-29'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2022-08-15', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change in size of plantar wart', 'timeFrame': '3 month', 'description': 'measurement the change in size of plantar wart'}, {'measure': 'the change in number of plantar warts', 'timeFrame': '3 month', 'description': 'measurement the change in number of plantar warts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plantar Wart']}, 'referencesModule': {'references': [{'pmid': '31241843', 'type': 'BACKGROUND', 'citation': 'Abeck D, Tetsch L, Luftl M, Biedermann T. Extragenital cutaneous warts - clinical presentation, diagnosis and treatment. J Dtsch Dermatol Ges. 2019 Jun;17(6):613-634. doi: 10.1111/ddg.13878.'}, {'pmid': '21219294', 'type': 'BACKGROUND', 'citation': 'Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.'}]}, 'descriptionModule': {'briefSummary': 'Warts are common skin infections caused by human papillomavirus (HPV), which can cause a variety of skin presentations according to its type, site and the immune status .Nongenital warts may be presented as common, plane, plantar, filiform, or mucosal warts .Most people are affected by cutaneous warts, either plantar warts or common warts .prevalence of skin warts is between 3% and 13% and plantar warts are about 30% of skin warts in western world .Majority of cases occur in adolescent and young adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:\\>18 years .\n* Sex: both males and females will be included.\n* Confirmed diagnosis by clinical and dermoscopic examination of plantar warts will be made\n\nExclusion Criteria:\n\n* Patients with history or evidenced hypersensitivity to any component used in this study.\n* Pregnancy \\& lactating.\n* Patients who receive immune suppressive therapy.\n* Patients who receive any wart treatment during the last 2 months before enrollment in the study.\n* Patients with systemic illness especially cardiac patients.\n* Patients who refused participation in the study'}, 'identificationModule': {'nctId': 'NCT05520658', 'briefTitle': 'Evaluation of the Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5 - Fluorouracil in Treatment of Plantar Warts', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of the Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5 - Fluorouracil in Treatment of Plantar Warts', 'orgStudyIdInfo': {'id': 'Soh-Med-22-07-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'patients will receive intralesional combined digoxin and furosemide , one session every 2 weeks for maximum 6 sessions', 'interventionNames': ['Drug: combined digoxin and furosemide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'patients will receive intralesional 5 fluorouracil mixed with 1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions .', 'interventionNames': ['Drug: 5 fluorouracil']}], 'interventions': [{'name': 'combined digoxin and furosemide', 'type': 'DRUG', 'description': 'one session every 2 weeks for maximum 6 sessions', 'armGroupLabels': ['group A']}, {'name': '5 fluorouracil', 'type': 'DRUG', 'description': '5 fluorouracil mixed with1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions .', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Osama R Elshrif, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'samah R Ahmed, resident', 'role': 'CONTACT', 'email': 'samah_ragab_post@med.sohag.edu.eg', 'phone': '01128636414'}, {'name': 'Essam A Nada', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at dermatology department at sohag teaching hospital', 'investigatorFullName': 'Samah Ragab Ahmed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-29', 'type': 'RELEASE'}, {'date': '2024-11-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Samah Ragab Ahmed, resident doctor at dermatology department at sohag teaching hospital, Sohag University'}}}}